The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types

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GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to develop blood tests to detect cancer early. The purpose of this study is to validate the ability of the pre-specified GRAIL Test to detect breast cancer and other invasive cancers, including hematologic malignancies, that will occur within one year of the first study blood draw.

Condition or disease

NeoplasmsCancer

Detailed Description:

Detection of early stage cancer may be possible through analysis of circulating cell-free nucleic acids (cfNAs) shed into the blood by tumors. GRAIL is using high-intensity sequencing (based on broad genomic coverage and deep sequencing) of cfNAs, combined with machine learning, to develop blood tests to detect cancer early. The purpose of this prospective, multi-center, observational cohort study is to validate an assay for the early detection of breast cancer and other invasive cancers, including hematologic malignancies. The study will collect blood samples from participants within 28 days of their screening mammogram. Additional blood samples will also be collected for a subset of participants. For participants who receive a cancer diagnosis during the study, archival tissue samples will be collected.

This is a prospectively enrolling cohort study with a pre-specified molecular analysis plan. A stratified case-cohort design will be employed to select cancer cases and non-cancer subjects who will be assayed. All cases of cancer (breast and non-breast cancer) will be selected. A random subset of the overall study cohort will also be selected.

Diagnosis of invasive cancer, including hematologic malignancies within one year after the first study blood draw. [ Time Frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months ]

Diagnosis of invasive cancers, including hematologic malignancies, that occur between 12 and 24 months after the first study blood draw, and cancer-specific mortality. [ Time Frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months ]

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